Safety and Efficacy of VAY736 in Patients With Primary Sjogren's Syndrome (pSS)

• ClinicalTrials.gov Identifier: NCT02962895
• Recruitment Status: Completed
• First Posted: November 15, 2016
• Last Update Posted: January 24, 2022
• Sponsor: Novartis Pharmaceuticals
• Information provided by (Responsible Party): Novartis ( Novartis Pharmaceuticals )

Tracking Information

• First Submitted Date: November 3, 2016
• First Posted Date: November 15, 2016
• Last Update Posted Date: January 24, 2022
• Actual Study Start Date: June 27, 2017
• Actual Primary Completion Date: June 30, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 5, 2020)

Change in multi-dimensional disease activity [ Time Frame: 24 weeks ]

Dose response measured by change multi-dimensional disease activity as assessed by the physician

Original Primary Outcome Measures (submitted: November 9, 2016)

Dose response [ Time Frame: 24 weeks ]

Dose response measured by change multi-dimensional disease activity as assessed by the physician

Current Secondary Outcome Measures (submitted: January 20, 2022)

• Change in patient-reported disease activity measures [ Time Frame: 24 weeks ]
  Dose response measured by change in patient-reported disease activity measures
• Change in quality of life measure by PRO [ Time Frame: 24 weeks ]
  Change in quality of life measure by patient reported outcome (PRO)
• Change in salivary gland function measure by flow rate [ Time Frame: 24 weeks ]
  salivary gland function measure by flow rate
• Incidence of Adverse events and Serious Adverse Events [ Time Frame: 24 weeks ]
  Number of participants with adverse events

Original Secondary Outcome Measures (submitted: November 9, 2016)

• Dose response [ Time Frame: 24 weeks ]
  Dose response measured by change in patient-reported disease activity measures
• Quality of Life [ Time Frame: 24 weeks ]
  Change in quality of life measure by PRO
• Salivary gland function [ Time Frame: 24 weeks ]
  Change in salivary gland function measure by flow rate
• Safety [ Time Frame: 24 weeks ]
  Incidence of Adverse events and Serious Adverse Events

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Safety and Efficacy of VAY736 in Patients With Primary Sjogren's Syndrome (pSS)
• Official Title: Study of Safety and Efficacy of Multiple VAY736 Doses in Patients With Moderate to Severe Primary Sjogren's Syndrome (pSS)
• Brief Summary: This study will determine the dose-response relationship of VAY736 for key efficacy and safety parameters
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: Primary Sjogren Syndrome

Intervention

• Biological: VAY736
  VAY736
• Other: Placebo
  Placebo control

Study Arms

• Experimental: VAY736 dose 1
  VAY736 low
  Intervention: Biological: VAY736
• Experimental: VAY736 dose 2
  VAY736 medium
  Intervention: Biological: VAY736
• Experimental: VAY736 dose 3
  VAY736 high
  Intervention: Biological: VAY736
• Placebo Comparator: Placebo
  Placebo control
  Intervention: Other: Placebo

• Publications *: Bowman SJ, Fox R, Dorner T, Mariette X, Papas A, Grader-Beck T, Fisher BA, Barcelos F, De Vita S, Schulze-Koops H, Moots RJ, Junge G, Woznicki JN, Sopala MA, Luo WL, Hueber W. Safety and efficacy of subcutaneous ianalumab (VAY736) in patients with primary Sjogren's syndrome: a randomised, double-blind, placebo-controlled, phase 2b dose-finding trial. Lancet. 2022 Jan 8;399(10320):161-171. doi: 10.1016/S0140-6736(21)02251-0. Epub 2021 Nov 30.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 30, 2021): 192
• Original Estimated Enrollment (submitted: November 9, 2016): 180
• Actual Study Completion Date: September 23, 2021
• Actual Primary Completion Date: June 30, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Fulfilled revised American European Consensus Group criteria for pSS
• Seropositive at screening for anti-Ro/SSA antibodies
• Screening ESSDAI value >=6 scored from 7 domains: articular, cutaneous, glandular, lymphoadenopathy, constitutional, biologic and hematologic.

Exclusion Criteria:

• Secondary Sjogren's syndrome
• Use of other investigational drugs
• Active viral, bacterial or other infections
• Positive hepatitis B, hepatitis C, HIV or tuberculosis test results at screening

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Argentina, Austria, Belgium, Chile, France, Germany, Hungary, Israel, Italy, Japan, Netherlands, Poland, Portugal, Romania, Russian Federation, Spain, Taiwan, United Kingdom, United States

Administrative Information

• NCT Number: NCT02962895
• Other Study ID Numbers: CVAY736A2201
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

• Current Responsible Party: Novartis ( Novartis Pharmaceuticals )
• Original Responsible Party: Same as current
• Current Study Sponsor: Novartis Pharmaceuticals
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Novartis
• Verification Date: January 2022